CAMBRIDGE BIOTECH HUMAN LYME IGG WESTERN BLOT (90111)— 510(k) K971169

Name: FDA 510(k) clearance K971169
Creator: U.S. Food and Drug Administration
Published: 1998-02-17

Substantially Equivalent

Cambridge Biotech Corp.

FDA 510(k) clearance K971169 for CAMBRIDGE BIOTECH HUMAN LYME IGG WESTERN BLOT (90111), Substantially Equivalent on 1998-02-17. Applicant: Cambridge Biotech Corp.. Device class: 2.

Clearance details

Applicant: Cambridge Biotech Corp.
Product code: Code LSR
Device class: Class 2
Regulation: 21 CFR 866.3830
Advisory panel: Microbiology
Date received: 1997-03-28
Decision date: 1998-02-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Rockville, MD, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code LSR

view all

K254295 — Sofia Lyme FIA; Sofia 2 Campylobacter FIA2026-07-10
K252627 — Lyme-ID IgG Test; Bio-ID8002025-11-14
K242872 — iDart Lyme IgM ImmunoBlot Kit2025-06-12
K233367 — iDart Lyme IgG ImmunoBlot Kit2024-08-12
K230863 — ZEUS Solinas Borrelia VlsE1/pepC10 IgG/IgM Test System; ZEUS Solinas Borrelia VlsE1/pepC10 IgG/IgM Control Kit2023-07-13

More clearances from Cambridge Biotech Corp.

view all

K971170 — CAMBRIDGE BIOTECH HUMAN LYME IGM WESTERN BLOT (90112)1998-02-17
K911958 — CYTOCLONE A & B EIA1991-07-30

Data sourced from openFDA. This site is unofficial and independent of the FDA.